Method for measurably improving oral health

ABSTRACT

The present invention provides a method to measurably improve oral health. The method includes use of a composition, including one or more active ingredients to measurably improve oral health, a system including the composition and a container encapsulating the composition, and a kit including a plurality of systems. Each system is configured to apply the composition directly to a surface.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/800,632, entitled SYSTEM FOR MEASURABLYIMPROVING ORAL HEALTH AND METHOD OF USING SAME, filed May 15, 2006.

FIELD OF INVENTION

The present invention generally relates to methods for measurablyimproving oral health. More particularly, the invention relates totechniques for measurably reducing an amount of plaque, tartar,gingivitis, periodontitis, and/or bleeding of the gums

BACKGROUND OF THE INVENTION

Unfortunately, poor oral health affects millions of people every year.Poor oral health may result in symptoms ranging bad breath, tooth decay,and tooth discoloration, to more serious health problems, such as gumdisease, tooth loss, heart disease, stroke, poorly controlled diabetesand preterm labor.

The presence of dental plaque, or simply plaque, in an oral cavity canlead to such oral and general health problems. Plaque can be defined asan organized, coherent, gel-like or mucoid material that includesmicroorganisms in an organic matrix derived from saliva andextracellular bacterial products such as glucans, fructans, enzymes,toxins, and acids. Plaque may also contain other cells, such asdesquamated epithelial cells, and inorganic components, such as calciumand phosphate. In general, dental plaque is a bacterial accumulation.Generally transparent and sticky, plaque accumulates around the teeth atthe cervical margin, and then grows apically.

Once plaque forms on a surface, the plaque resists removal, and usuallycan be removed only by mechanical means, such as, for example, bybrushing and flossing the affected areas. If not removed, however, thepresence of plaque can give rise to tartar formation, tooth decay,gingivitis, periodontitis, and other health problems.

Tartar is a hard, calcified plaque material that exhibits a yellowish orbrownish color. Tartar forms as a result of minerals (e.g., thosepresent in saliva and gum pockets) reacting with plaque material to forma rough calculus. Calculus generally arises from the nucleation ofcalcium phosphate, often in areas where the large salivary gland ductssecrete their saliva. As such, calculus can form on surfaces not coveredby the oral mucosa (supragingival) or on surface located apical to thesoft tissue margin of the gingiva (subgingival).

Tartar adheres to hard surfaces such as enamel, roots, and dentaldevices, such as dentures, bridges, crowns, and the like, and isgenerally more difficult to remove than plaque. Brushing and flossingare normally not sufficient to remove tartar from a surface.

If left untreated, tartar buildup can be problematic in several regards.For example, the rough, porous surface of tartar serves as a breedingground for additional bacteria, which can calcify and form additionaltartar. The bacteria growth from both plaque and tartar can, in turn,lead to tooth decay, gum disease, gingivitis, periodontitis, tooth loss,as well as systemic health problems.

Gingivitis is the beginning stage of periodontitis and is often causedby long-term effects of plaque and tartar buildup. Gingivitis ischaracterized by red, swollen gums. A periodontal probe will oftenmeasure about 3 to about 5 mm in depth into the space between the teethand gums at the early stages of gingivitis. At this stage, gingivitiscan often be reversed with proper treatment.

Left untreated, gingivitis will likely progress to advancedperiodontitis. At this stage of gum disease, plaque and tartar aretypically present supragingival and subgingival and an infection hasdestroyed bone around a tooth. In general, at this stage, a family ofchronic inflammatory infections are affecting the supporting tissues ofthe dentition. Teeth often become loose, and the pocket depth may rangebetween about 5 mm and about 8 mm at this stage.

As noted above, in addition to the health concerns, plaque and tartarmay give rise to cosmetic problems. Tartar can be particularlyproblematic because it is difficult to remove and because of itsyellowish or brownish color. Moreover, because the surface of tartar isrough and porous, tartar tends to absorb colors from other sources(e.g., coffee, tea, tobacco, smoke, red wine and the like), and thus thepresence of tartar exacerbates cosmetic tooth coloration typicallyassociated with such other sources.

Typical self-administered techniques for promoting oral health includebrushing, flossing, and rinsing with a mouth rinse that typicallyincludes an antimicrobial agent. Although such techniques may workrelatively well at mitigating plaque buildup, such techniques are notthought to be effective at removing existing tartar from a surface.Furthermore, although flossing is thought to reduce plaque buildup,relatively few people in the general population floss as often as theyshould (at least once a day). In a recent study, only 27% of consumerssaid they flossed once a day.

The usual methods of preventing tartar buildup include brushing with atartar control toothpaste. Although such toothpastes, if used regularly,may prevent additional buildup of tartar, the toothpastes are notthought to be effective at removing existing tartar from tooth anddevice surfaces.

Typical methods of removing existing tartar typically include scaling orroot planing, both of which are performed by dentists or hygienists withthe aid of specialized tools. Although these techniques work well, theyare relatively expensive and time consuming.

Accordingly, improved techniques for measurably reducing an amount oftartar, plaque, gingivitis, gum bleeding, periodontitis, and the likeare desired.

SUMMARY OF THE INVENTION

The present invention provides a method for measurably improving oralhealth. More particularly, the invention provides techniques for using acomposition, system, and kit. The composition includes one or moreactive ingredients to measurably reduce an amount of plaque, tartar,gingivitis, including gum bleeding, and/or other periodontal disease, asystem includes the composition and a container, and a kit includes aplurality of systems.

While the ways in which the invention addresses the various drawbacks ofknown methods will be described in more detail below, in general, thepresent invention provides a relatively inexpensive, safe technique forthe measurable improvement of oral care indices, such as Loe and SilnessGingival Index (1963) (GI), the Turesky Modification (1970) of theQuiqley and Hein Plaque Index (PI), Volpe-Manhold Index for Calculus(1965) (V-MI). The method is relatively easy to use, does not require avisit to a dentist office, and does not damage the surface of toothenamel.

In accordance with various embodiments of the invention, a method formeasurably improving oral health includes use of a system that includesa composition, having one or more active ingredients to measurablyimprove oral health, and a container for enclosing and applying thecomposition.

In accordance with one embodiment of the invention, a system includes aviscous composition including at least one active ingredient and acontainer configured to dispense the viscous composition. In accordancewith various aspects of this embodiment, the viscous composition isdesigned to maintain the active ingredient(s) in contact with a surfacefor an extended period of time. Exemplary compositions have a viscositygreater than about 20,000 cp, preferably greater than about 30,000 cp,and more preferably greater than about 35,000 cp. The viscosity of thecompositions may range from about 20,000 to about 250,000 cp, preferablyabout 25,000 to about 100,000, and more preferably about 30,000 to about50,000 cp. Suitable active ingredients include cetylpyridinium chloride(CPC), zinc salts, other antimicrobial agents, and other ingredientsknown to improve (typically reduce) measurable oral health care indices.In accordance with additional aspects of this embodiment, the containerencapsulates a single dose of the composition, and the system includes aplurality of containers and doses. In accordance with yet furtheraspects, the container is configured to facilitate application of thecomposition to specific areas within an oral cavity. In accordance withyet additional aspects of this embodiment, the system is designed toimprove one or more oral health indices selected from the group of GI,PI, and V-MI.

In accordance with another embodiment of the invention, a systemincludes a composition, having a plurality of active ingredients tomeasurably improve oral health, and a container to hold the composition.In accordance with various aspects of this embodiment of the invention,the composition includes a carrier having a thickening agent, whereinthe composition is configured to maintain the plurality of activeingredients in contact with a surface for an extended period of time.Exemplary thickening agents suitable for use in the composition includehydroxyethylcellulose, and other pharmaceutically acceptable thickeners,and exemplary active ingredients include CPC, zinc salts, otherantimicrobial agents, and similar agents known to reduce tartar orplaque or gingivitis. In accordance with additional aspects of thisembodiment, the container encapsulates a single dose of the composition,and the system includes a plurality of containers and doses. Inaccordance with yet further aspects, the container is configured tofacilitate application of the composition to specific areas within anoral cavity. In accordance with yet additional aspects of thisembodiment, the system is designed to improve one or more oral healthindices selected from the group of GI, PI, and V-MI.

In accordance with a further embodiment of the invention, a systemincludes a composition, having one or more active ingredients tomeasurably improve oral health and a carrier including a thickeningagent, and a container to hold the composition. Exemplary thickeningagents suitable for use in the composition includehydroxyethylcellulose, glycerin, and other pharmaceutically acceptablethickeners, and exemplary active ingredients include CPC, zinc salts,other antimicrobial agents, and similar agents known to improve oralhealth.

In accordance with additional embodiments, a system includes a containerthat encapsulates a single dose of the composition. In accordance withalternative embodiments, the container encloses multiple doses.

In accordance with various additional embodiments, the composition,system, and kit are designed to improve one or more oral health indicesselected from the group of GI, PI, and V-MI.

In accordance with various additional embodiments, a method includesdispensing a composition from a sealed container by rupturing the sealedcontainer and applying a single dose of the composition directly to thesurface. In accordance with another example, the composition is appliedafter brushing, flossing, and/or rinsing, and is applied before extendedrest or bedtime to allow the active ingredients to stay in contact witha surface for an extended period of time

BRIEF DESCRIPTION OF THE DRAWINGS

The exemplary embodiments of the present invention will be described inconnection with the appended drawing figures in which like numeralsdenote like elements and:

FIG. 1 illustrates a perspective view of a dispensing device inaccordance with exemplary embodiments of the invention; and

FIGS. 2A-2D illustrate, respectively, left view, front view, right viewand a top view of an exemplary container in accordance with an exemplaryembodiment of the invention.

DETAILED DESCRIPTION

The present invention provides a method to measurably improve oralhealth. More particularly, the invention provides a method for using acomposition, system, and kit to measurably improve one or more oralhealth care indices such as GI, PI, and V-MI. The method of theinvention can be used to improve oral health of various animals, isparticularly well suited for the treatment of humans.

As used throughout this application, the term “surface” includes anysurface on which plaque, tartar, or gum disease may form. Exemplarysurfaces include teeth (both supragingival and subgingival), gums, anddental appliances such as bridges, crowns, fillings, braces, and thelike. Further, the term “measurably improve” means a measurabledifference between an amount measured without use of the system of thepresent invention and with or after use of the system. The measurementsmay be compared for the same surface (before and after) or between testand control groups.

Viscous Composition

In accordance with exemplary embodiments of the invention, a method formeasurably improving oral health includes a use of a viscouscomposition, including an active ingredient. As explained in greaterdetail below, the composition is designed to maintain the activeingredient in contact with a surface for an extended period of time toallow the active ingredient(s) to stay in contact with possibly affectedareas on the surface.

Exemplary active ingredients suitable for use with systems of theinvention include one or more of the following: cetylpyridinium chloride(CPC), dicalcium phosphate dehydrate, hydrogen peroxide, sanguinariaextract, sodium bicarbonate, sodium lauryl sulfate, sodium fluoride,stannous fluoride, sodium monofluorophosphate (MFP), zinc salts such aszinc chloride, zinc acetate, zinc citrate, zinc oxide and zincgluconate, alkyl dimethyl amine oxide, alkyl dimethyl glycine,eucalyptol, menthol, methyl salicylate, thymol, sodium citrate,peppermint oil, sage oil, polymethylsiloxane, polxamer, and stannouspyrophosphate. Other now known or hereafter devised actives may also beused. For example, any agent, which alone or in combination is able toprevent or alleviate the severity of problems associated with dentitionmay be utilized. Such may include anti-caries agents and the like;agents useful in reducing tooth hypersensitivity, such as potassiumnitrate, strontium chloride and/or the like; and/or plaque and calculusreducing agents, such as, for example, chlorhexidine, quaternaryammonium compounds (e.g. benzethonium chloride, domphen bromide, etc.),triclosan, herbal compounds (e.g. sanguinarine), stannous salts, complexphosphates (e.g., pyrophosphates), SLS (e.g. sodium lauryl sulfate),hydrogen peroxide, and/or the like.

An amount of the active ingredient for use within compositions suitablefor uses with the invention varies in accordance with the dosage sizeand particular ingredient(s). In general, each active or activesselected will be used in a suitably effective amount, generally on theorder of less than about 10 wt %, and more preferably 5 wt % or less. Anamount of active may also be desirably selected to be within governmentguidelines, such as guidelines by the Food and Drug Administration inthe USA. In particularly preferred compositions, the active ingredientis present in an amount of about 0.001 wt % to about 1.5 wt %, within anamount of about 0.025 wt % to about 1.0 wt %, or even within an amountabout 0.05 wt % to about 0.7 wt %. All percentages set forth herein arein weight percent of the total composition, unless otherwise indicated.

In accordance with particular examples of this exemplary embodiment ofthe invention, the active ingredient includes CPC. In one case, the CPCis present in an amount of about 0.001% to about 1%, preferably about0.01% to about 0.5%, and more preferably about 0.05% to about 0.25% orabout 0.045% to about 0.1%.

In accordance with other examples, the active ingredient includes zincgluconate. In one case, the zinc gluconate is present in an amount ofabout 0.001% to about 1.5%, preferably about 0.01% to about 1.0%, andmore preferably about 0.05% to about 0.75%.

In accordance with further aspects, the composition includes a thickenerto obtain the desired viscosity. Suitable thickening agents includesubstances which increase the viscosity of the composition, cause thecomposition to gel or coagulate, or the like, such as food-grade orpharmaceutical grade thickeners, including, for example,hydroxyethylcellulose. For example, hydroxyethylcellulose, hydroxypropylmethylcellulose, carrageenan, guar gum, methylcellulose,methyethylecellulose, acceptable non-ionic thickeners, and/or the like.The thickener may be present in an amount of about 0.01 to about 10%,preferably about 0.1 to about 7%, and more preferably about 1% to about5%.

The composition may also include a humectant such a glycerin, which maybe present in an amount of about 0.01% to about 15%, preferably about0.1% to about 10%, and more preferably about 1 to about 7%. When used,the humectant may facilitate maintaining the composition in a liquidform and may help maintain a desired viscosity of the composition. Inaddition, glycerin may facilitate maintaining one or more of the activeingredients in an ionic form and may facilitate the transport of theactive ingredients through the composition.

The composition may also include a suitable diluent. Exemplary diluentsfor use with the present composition include water, alcohols, and oils.In accordance with particular examples of the invention, the compositionincludes purified water in an amount of about 80% to about 99%,preferably about 85% to about 95%, and more preferably about 88% toabout 92%.

The composition may also include sugar alcohols such as sorbitol thatact as a sweetener and also as a humectant and/or emulsifier. When used,sorbitol or other sugar alcohol is present in an amount of about 0.001%to about 0.5%, preferably about 0.01% to about 0.1%, and more preferablyabout 0.025% to about 0.075%.

The composition may also include a natural or artificial sweetener suchas sucralose, ace-K, sodium, saccharin, aspartame, and/or the like,which, when included in the composition, is present in an amount ofabout 0.001% to about 1.5%, preferably about 0.01% to about 1%, and morepreferably about 0.25% to about 0.75%.

Colorants may also be added to the composition as desired. In accordancewith various aspects, the composition includes colorants, such that whenthe composition is applied to or proximate the gingiva, the compositionhas a color indicative of healthy gingiva—i.e., the composition is pinkin color. Providing a composition having a color indicative of healthygingiva provides added incentive to users to continue using thecomposition, which in turn promotes measurable improvement in oralhealth indices.

Colorants may be present in any desired amount. By way of particularexample, the colorants may include Red #33 and Red #40, available fromPylam in an amount of about 0.000001% to about 0.00018%, and morepreferably about 0.00050% to about 0.00099.

The composition also optionally includes flavorants such as cinnamonoil, clove oil, mint flavorings, citrus flavorings, and the like. By wayof one particular example, a composition includes cinnamon oil presentin an about of about 0.001% to about 2%, preferably about 0.01% to about1%, and more preferably about 0.1% to about 0.5%; and clove oil in anamount of about 0.001% to about 2%, preferably about 0.002% to about 1%,and more preferably about 0.003% to about 0.0075%.

Preferably, the composition is configured to maintain the composition incontact with a surface for an extended period of time, which has severaladvantages over traditional compositions used to promote oral health. Inthis regard, preferably the composition is both viscous and exhibitshigh micro adhesiveness. In accordance with one preferred embodiment,advantageously the composition is both viscous and “sticks” to a surfaceto which it is applied. In accordance with one aspect of a particularlypreferred embodiment of the present invention, the configuration of thecomposition permits relatively small amounts of the composition andconsequently the active agent(s) to be used to effectively prevent orremove plaque and/or tartar buildup on a surface. This is advantageous,not only from an economic viewpoint, but it also reduces an amount ofthe composition that may be ingested.

In general, the viscosity of the composition is suitably selected tofacilitate easy delivery of the composition from its container, whilealso maintaining the composition in contact at particular areas withinan oral cavity, such as the crevices within teeth and at the toothgingival margin. In accordance with further embodiments of theinvention, the viscosity is low enough to allow application of thecomposition to desired locations within the oral cavity.

Exemplary compositions have a viscosity greater than about 20,000 cp,preferably greater than about 30,000 cp, and more preferably greaterthan about 35,000 cp. By way of more particular examples, the viscosityof compositions range from about 20,000 to about 250,000 cp, preferablyabout 25,000 to about 100,000, and more preferably about 30,000 to about50,000 cp, and yet more preferably about 35,000 to about 45,000 cp. Theviscosity values as set forth herein are measured using a Brookfield,Model DV-II+ Pro viscometer, spindle # 6, 10 RPM for 90 seconds at 25 C.

Active Plus Thickener

In accordance with another embodiment of the invention, a compositionincludes one or more active ingredients in a carrier, which includes athickening agent. The active ingredient and thickening agent may includeany one or more of the active ingredients and thickening agents notedabove in the respective weight percents noted above. The composition mayalso include any of the optional ingredients such as sweeteners,flavorants, and colorants as set forth herein.

By way of example, a composition in accordance with this embodiment ofthe invention includes CPC and zinc gluconate as the active ingredientsand hydroxyethylcellulose as the thickener. In this case, the CPC ispresent in an amount of about 0.001% to about 1%, preferably about 0.01%to about 0.5%, and more preferably about 0.05% to about 0.25% or about0.045% to about 0.1%; the zinc gluconate is present in an amount ofabout 0.001% to about 1.5%, preferably about 0.01% to about 1.0%, andmore preferably about 0.05% to about 0.75%; and thehydroxyethylcellulose is present in an amount of an amount of about 0.01to about 10%, preferably about 0.1 to about 7%, and more preferablyabout 1% to about 5%.

Multiple Active Ingredients

In accordance with another embodiment of the invention, a compositionincludes multiple active ingredients. The plurality of activeingredients may include any combination of the active ingredients notedabove in the weight percents noted above. The composition may alsoinclude any of the optional ingredients such as sweeteners, flavorants,and colorants as set forth herein.

In accordance with one aspect of this embodiment, the composition has aviscosity greater than about 20,000 cp, preferably greater than about30,000 cp, and more preferably greater than about 35,000 cp. By way ofmore particular examples, the viscosity of compositions ranges fromabout 20,000 to about 250,000 cp, preferably about 25,000 to about100,000, and more preferably about 30,000 to about 50,000 cp, and yetmore preferably about 35,000 to about 45,000 cp. In accordance withanother embodiment, the composition includes a thickening agent, whichis present in an amount of an amount of about 0.01 to about 10%,preferably about 0.1 to about 7%, and more preferably about 1% to about5%.

By way of one particular example, a composition in accordance with thisembodiment of the invention includes CPC and zinc gluconate as theactive ingredients. In one case, the CPC is present in an amount ofabout 0.001% to about 1%, preferably about 0.01% to about 0.5%, and morepreferably about 0.05% to about 0.25%; and the zinc gluconate is presentin an amount of about 0.001% to about 1.5%, preferably about 0.01% toabout 1.0%, and more preferably about 0.05% to about 0.75%.

Active Ingredient and Colorant

In accordance with this embodiment of the invention, a compositionincludes one or more active ingredients and a colorant indicative ofhealthy gingiva. In this case, the color of the composition is more thanmerely decorative. It serves the function of encouraging those that usethe product to continue to use the product because there is an immediateappearance, upon application of the composition, that the composition ispromoting healthy gingiva.

System

FIG. 1 and FIGS. 2A-2D illustrate an enclosed, single-dose dispensingsystem 100 suitable for applying a composition 102 (e.g. a compositiondescribed herein) to a surface. System 100 includes a resilientcontainment portion 104 and an applicator portion 106. Applicatorportion 106 further includes a severed or scarred area 108 and a sealedend 110.

Composition 102 is dispensed from system 100 by severing or rupturing aportion of device 100 (e.g., at or near scarred area 108) to exposecomposition 102 contained within system 100. Composition 102 is thenexpelled through applicator 106 to a desired area—e.g., a tooth gummargin of a user—by squeezing resilient portion 104 to cause thecomposition to flow from resilient portion 104 through applicator 106.

As noted above, system 100 may be configured to apply a composition to aspecific area within an oral cavity. In this case, applicator 106 mayhave a desirably small cross-section across applicator 106. Inaccordance with specific examples of the present invention, across-sectional dimension, taken along line A-A, is about 0.001″ toabout 0.2″, preferably about 0.05″ to about 0.01″, and more preferablyabout 0.06″ to about 0.09″.

Resilient portion 104 is designed to fit comfortably between two fingers(e.g., a thumb and an index finger) of a user, such that the compositionis expelled by pressing the two fingers, on opposite sides of portion104, together. In accordance with various examples of the invention,portion 104 has a cross-sectional dimension, taken along line B-B, ofabout 0.1″ to about 2″, preferably about 0.25″ to about 1″, and morepreferably about 0.4″ to about 0.6″.

A single-dose size may vary in accordance with several factors, such asthe particular active ingredient, the dilution of the composition, andthe like. Exemplary dose sizes for purpose of illustration range fromabout 0.5 mg to about 8 mg, preferably about 1 mg to about 7 mg, andmore preferably about 2 mg to about 5 mg.

Method of Measurably Improving Oral Health

A method of measurably improving oral health includes applying acomposition including one or more of the active ingredients describedherein to a surface and maintaining the composition in contact with thesurface for an extended period of time.

The composition may be applied using a variety of methods such as with aswab, with a syringe, or using any other means capable of dispensing thecomposition and applying a thin film of gel on the teeth and gums. Inaccordance with various aspects of this embodiment, the composition isselectively applied using system 100. More particularly, composition 102is applied though chute 106 to, e.g., a tooth/gingiva interface, suchthat the composition contacts both supragingival and subgingival areaswhere plaque and tartar is likely to form. Unlike most methods ofpromoting oral health, the method of this embodiment allows for direct,selective application of the composition to desired areas of a surface.Thus, less composition may be required to perform the task of measurablyimproving oral health, because the composition is not ubiquitouslyapplied to an oral cavity.

In accordance with one aspect of this embodiment, a measurabledifference of a gingivitis index (e.g., the Loe and Silness GingivalIndex (1963)) is obtained by using the system of the present invention.More particularly, a measurable difference in the GI is obtained byapplying a composition, e.g., from within the container, to an area(e.g., proximate an inflamed gum tissue, such as at the gum/tooth marginnear the inflamed area). In accordance with various aspects of thisembodiment, a single dose of the composition is applied after brushingteeth, flossing between teeth, and/or rinsing an oral cavity, and isapplied such that the composition remains in contact with the affectedarea for an extended period of time. By way of particular example, thecomposition can be applied at before an extended period of rest orbedtime to mitigate disruption of the composition/surface interface andto facilitate maintaining the composition in contact with the surfacefor an extended period.

In accordance with another aspect, a measurable difference of a plaqueindex, e.g., the Turesky Modification (1970) of the Quiqley and HeinPlaque Index (PI) is obtained by using the method of the presentinvention.

In accordance with another aspect, the method is used as described abovein connection with obtaining a measurable difference in the GI.

In accordance with yet a further aspect of this exemplary embodiment, ameasurable difference in a tartar index—e.g., the Volpe-Manhold Index(V-MI)—is obtained by using the method of the present invention asdescribed herein. As used herein, a “measurable difference” means areduction in one or more of the selected indices of on the order ofabout 20% or more. In accordance with yet another embodiment ameasurable improvement in a stain index—e.g., the Lobene Stain Index(SI)—is obtained using the system of the present invention.

SPECIFIC EXAMPLES

The following non-limiting examples illustrate measurable improvementsin various indices using the method in accordance with variousembodiments of the invention. These example are merely illustrative, andit is not intended that the invention be limited to the examples.Compositions for use in accordance with the present invention mayinclude the ingredients listed below as well as additional and/oralternative inert materials, preservatives, and other constituentstypically found in compositions for promoting oral health. In the casewhere exemplary inert materials and/or preservatives are listed, theseingredients are merely exemplary, and it is understood that othersimilar ingredients may be substituted for the materials listed in theexamples below.

Example 1 Reduction in V-MI

A pale light pink viscous gel, having a viscosity of about 40,000 cp,with cinnamon-clove characteristic odor and taste is formed by admixingthe following ingredients in the amounts shown. TABLE 1 ExemplaryIngredient Supplier Weight % Wt % Range Purified Water Copacker 91.603 80-99 Glycerin USP Acme-Hardesty 5.000  0.01-15 HEC 250 HXHercules-Aqualon 2.000  0.01-10 Sorbitol Roquette 0.050 0.001-0.5Sucralose Tate & Lyle 0.400 0.001-1.5 Cetylpyridinium Dastech 0.1000.001-1   Chloride Zinc Gluconate American Ingredients/ 0.592 0.001-1.5USP Pharmachem Inc. Cinnamon (Oil) Berje 0.250 0.001-2   Clove (Oil)Berje 0.005 0.001-2   Red #40 (1% sol.) Pylam 0.00099 0.000001-0.001 

A clinical study comparing the composition of Example 1 to a placebo anda commercial mouth rinse including CPC was conducted. Each group startedwith 25 people. At the conclusion of the 6 week test period, there wasan observable/measurable difference in the quality and thickness ofcalculus in the group using the composition of Example 1, compared tothe placebo and the mouth rinse. A significant disruption of calculusbridges or masses of calculus was observed in subjects using thecomposition of Example 1.

A visibly noticeable amount of tartar was removed from the surface ofthe teeth after the six-week period.

Example 2 Reduction in GI

A clinical study comparing the composition of Example 1 to a placebo anda mouth rinse including CPC was conducted. Each group started with 25people. At the conclusion of a six week test period, there was anobservable/measurable difference in the improvement of the GI for thegroup using the composition of Example 1, compared to the groups usingthe placebo and the rinse. The difference was statistically significant(p value≦0.05, based on ANCOVA results, adjusting for baseline value andmultiple comparisons) in both absolute and percent improvement of GIbetween the groups.

Example 3 Reduction in PI

A clinical study comparing the composition of Example 1 to a placebo anda mouth rinse including CPC was conducted. Each group started with 25people. At the conclusion of a six week test period, there was anobservable/measurable difference in the improvement of the PI for thegroup using the composition of Example 1, compared to the groups usingthe placebo and the rinse.

Although exemplary embodiments of the present invention are set forthherein, it should be appreciated that the invention is not so limited.Various modifications, variations, and enhancements in composition andmethod set forth herein may be made without departing from the spiritand scope of the present invention.

1. A method to measurably improve an oral health index comprising: a.providing at least one system, the at least one system including acomposition within a container wherein the composition comprises anactive ingredient for measurably improving oral health; and b. applyingthe composition to a surface within an oral cavity; wherein the oralhealth index comprises at least one of a gingival index, a plaque indexand a calculus index and wherein the viscosity of the composition isgreater than about 20,000 centipoise.
 2. The method of claim 1, whereinthe viscosity of the composition is about 20,000 centipoise to about250,000 centipoise.
 3. The method of claim 2, wherein the viscosity ofthe composition is about 25,000 to about 100,000 centipoise.
 4. Themethod of claim 3, wherein the viscosity of the composition is about30,000 to about 50,000 centipoise.
 5. The method of claim 1, wherein theactive ingredient comprises at least one of cetylpyridinium chloride,dicalcium phosphate dehydrate, hydrogen peroxide, sanguinaria extract,sodium bicarbonate, sodium lauryl sulfate, stannous fluoride, zinc saltssuch as zinc chloride, zinc acetate, zinc citrate, and zinc gluconate,alkyl dimethyl amine oxide, alkyl dimethyl glycine, eucalyptol, menthol,methyl salicylate, thymol, sodium citrate, peppermint oil, sage oil,polymethylsiloxane, polxamer, and stannous pyrophosphate.
 6. The methodof claim 1, further comprising a kit including a plurality of systems.7. A method to measurably reduce existing tartar comprising: a.providing a system including a composition within a container, thecomposition including an active ingredient and a thickening agent formeasurably reducing existing tartar and the container including aresilient vial and a spout for targeted delivery of the composition; andb. applying the composition to a surface within an oral cavity.
 8. Themethod of claim 7, wherein the viscosity of the composition is about20,000 centipoise to about 250,000 centipoise.
 9. The method of claim 8,wherein the viscosity of the composition is about 25,000 to about100,000 centipoise.
 10. The method of claim 9, wherein the viscosity ofthe composition is about 30,000 to about 50,000 centipoise.
 11. Themethod of claim 7, wherein the active ingredient comprises at least oneof cetylpyridinium chloride, dicalcium phosphate dehydrate, hydrogenperoxide, sanguinaria extract, sodium bicarbonate, sodium laurylsulfate, stannous fluoride, zinc salts, alkyl dimethyl amine oxide,alkyl dimethyl glycine, eucalyptol, menthol, methyl salicylate, thymol,sodium citrate, peppermint oil, sage oil, polymethylsiloxane, polxamer,and stannous pyrophosphate.
 12. The method of claim 7, wherein thethickening agent comprises at least one of hydroxyethylcellulose,hydroxypropyl methylcellulose, carrageenan, guar gum, methylcellulose,and methyethylecellulose.
 13. The method of claim 12 wherein thethickening agent is present in an amount of about 0.01 wt % to about 10wt %.
 14. The method of claim 13, wherein the thickening agent ispresent in an amount of about 0.1 wt % to about 7 wt %.
 15. The methodof claim 14, wherein the thickening agent is present in an amount ofabout 1 wt % to about 5 wt %.
 16. A method to measurably improve an oralhealth index comprising the steps of: a. providing at least one system,the at least one system including a composition within a container,wherein the composition comprises a plurality of active ingredients formeasurably improving oral health and a thickener; b. applying thecomposition to a surface within an oral cavity; and c. maintaining thecomposition in contact with the surface for an extended period of time;wherein the oral health index comprises at least one of a gingivalindex, a plaque index and a calculus index.
 17. The method of claim 11,wherein the viscosity of the composition is greater than about 20,000centipoise.
 18. The method of claim 13, wherein the viscosity of thecomposition is about 25,000 to about 100,000 centipoise.
 19. The methodof claim 14, wherein the viscosity of the composition is about 30,000 toabout 50,000 centipoise.
 20. The method of claim 16, wherein the activeingredient comprises at least one of cetylpyridinium chloride, dicalciumphosphate dehydrate, hydrogen peroxide, sanguinaria extract, sodiumbicarbonate, sodium lauryl sulfate, stannous fluoride, zinc salts suchas zinc chloride, zinc acetate, zinc citrate, and zinc gluconate, alkyldimethyl amine oxide, alkyl dimethyl glycine, eucalyptol, menthol,methyl salicylate, thymol, sodium citrate, peppermint oil, sage oil,polymethylsiloxane, polxamer, and stannous pyrophosphate.